Director of Design Engineering
The Opportunity:
The Director of Design Engineering is Marketlab's senior product-engineering authority, responsible for the technical integrity of products from early concept through release, transfer, and lifecycle change. This individual will lead a scalable Design Engineering function while staying close enough to priority work to provide hands-on technical judgment and capacity. The Director will lead and develop the internal team, determine when specialized outside expertise is needed, and remain accountable for the quality and completeness of externally produced engineering work.
Functional/Technical Competencies:
- Product Design & Development Leadership: Lead physical-product development from customer need and concept through technical definition, design, prototyping, verification, validation, release, transfer, and lifecycle change.
- Engineering Depth & Judgment: Apply strong judgment across requirements, CAD and drawings, tolerancing, materials, manufacturing methods, BOMs, design risk, testing, failure analysis, and technical tradeoffs.
- Design Controls & Technical Rigor: Drive practical, risk-based standards for design inputs and outputs, reviews, traceability, documentation, approvals, and engineering changes.
- Verification & Validation Strategy: Translate product requirements and risks into credible evidence plans, including test methods, fixtures, internal equipment, external laboratories, clinical input, and third-party certification when appropriate.
- Manufacturability & Supplier Engineering: Evaluate supplier capability, manufacturability, samples, deviations, transfer readiness, and product changes across domestic and international supply partners.
- Technical Team & Partner Leadership: Set priorities, review engineering output, coach technical judgment, build repeatable capability, and direct external engineers and specialty partners.
Behavioral Competencies:
- Cross-Functional Influence: Build alignment across Product Management, Sourcing, Quality, Regulatory, Operations, Manufacturing Engineering, Sales, and Marketing while respecting each function's decision rights.
- Decision Making & Prioritization: Make timely, risk-based technical decisions and focus engineering capacity on work that materially affects customers, growth, margin, availability, product integrity, or execution risk.
- Clear Communication: Explain complex technical issues, tradeoffs, evidence, and recommendations in language that enables practical business decisions.
- Practical Problem-Solving: Bring structure to ambiguous problems, test assumptions, and balance necessary rigor with speed, cost, and operational reality.
What You'll Do:
- Define and continuously improve Marketlab's Design Engineering operating model, including technical standards, required deliverables, review gates, approval authority, and decision rights by project type and risk.
- Lead engineering work across the product lifecycle, from translating customer and business needs into design requirements through concepts, CAD, drawings, tolerances, materials, BOMs, prototypes, verification, validation, release, transfer, and engineering change.
- Serve as the senior Design Engineering approver for product requirements, specifications, drawings, materials, configurations, supplier deviations, technical risk decisions, and design changes.
- Chair design and technical reviews at meaningful project milestones; test requirements completeness, risk, manufacturability, verification strategy, supplier readiness, and unresolved tradeoffs before commitment.
- Set risk-based verification and validation strategies, including the evidence required, test methods, fixtures, equipment, laboratories, clinical input, and third-party expertise appropriate to the product.
- Partner with Product Management to translate customer problems and portfolio priorities into technically sound development plans, and provide clear guidance on feasibility, cost, timing, risk, and alternatives.
- Partner with Quality and Regulatory to ensure design controls, risk management, technical files, material declarations, product claims, validation evidence, and change records are appropriate and complete for applicable requirements.
- Partner with Sourcing, suppliers, Operations, and Manufacturing Engineering to assess technical capability and manufacturability, resolve sample or deviation issues, and define when design outputs are ready for process development and transfer.
- Scope and direct external engineering, testing, and specialty work; select the right partner, set milestones and deliverables, review technical output, control changes, and accept the final work product.
- Lead, develop, and allocate the Design Engineering team; review work quality, coach technical judgment, establish reusable methods and standards, and identify future capability or capacity needs.
- Remain hands-on on priority projects by providing technical analysis, troubleshooting, design review, and direct engineering support where the business needs senior judgment or additional capacity.
What You'll Need:
The ideal candidate will have:
- Bachelor's degree in mechanical engineering, biomedical engineering, product design engineering, or a closely related discipline; an advanced degree is helpful but not required.
- Substantial progressive experience leading physical-product design and development through release, transfer, and lifecycle change, including meaningful hands-on engineering work.
- Demonstrated strength in requirements, CAD and drawings, materials and manufacturing methods, tolerancing, BOMs, prototyping, verification, validation, risk management, and design reviews.
- Experience making and documenting senior technical decisions involving product requirements, material or configuration choices, tolerances, supplier deviations, test evidence, and design changes.
- Experience working with domestic and international suppliers and evaluating technical capability, manufacturability, samples, deviations, and transfer readiness.
- Leadership experience establishing engineering standards, reviewing technical work, developing talent, allocating capacity, and managing external engineering or testing partners.
- Healthcare products, medical devices, regulated products, or ISO 13485 design-control experience is strongly preferred.
- Practical commercial judgment and the ability to distinguish necessary rigor from unnecessary complexity while protecting product integrity, customer commitments, and business outcomes.
Benefits:
- Paid parental leave
- Scholarship reimbursement
- 401k match
- Benefits effective day one of employment
- Paid short term disability leave
- Flexibility with work from home
- Generous PTO policy that starts on day one
- Paid holidays
- Health and wellness program
- Employee discount program within our family of companies
